Implementing CAPABLE in PSH

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 50 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Implementing CAPABLE in Permanent Supportive Housing

Conditions

Accidental Fall, Frailty, Depression, Activities of Daily Living, Housing Problems

Being tested

CAPABLE: Community Aging in Place-Advancing Better Living for Elders

Medical subject headings

Frailty, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• CAPABLE: Community Aging in Place-Advancing Better Living for EldersBehavioural

  CAPABLE is a client-directed home-based intervention that consists of time-limited services from an occupational therapist, a nurse, and a handyman working collaboratively with the older adult client. In most cases, the OT makes 6 visits, the RN makes 4 visits, and a handyman makes 1 to 2 visits to make any modifications to a person's home during a 6-month period. The first visits for the OT and RN are usually 90 minutes each and the later ones are usually an hour each. Visits are spaced to enable older adults to practice new strategies learned in the previous visit. There should be a clear "conclusion/graduation," with the older adult understanding how to use their new skills and apply them to future situations.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Activities of Daily Living Limitations Score

   The modified Katz Activities of Daily Living (ADL) Index is an 8-item questionnaire that was completed by participants to rate their ability to perform daily activities, such as bathing, toileting, eating, and dressing, across a 5-point Likert scale (1 = no difficulty, 2 = a little difficulty, 3 = moderate difficulty, 4 = a lot of difficulty, 5 = unable to do). Items are summed to obtain a score with minimum and maximum values of 8 to 40, respectively, whereby higher scores represent greater difficulty performing ADLs.

   Measured: Change of ability to perform activities of daily living from baseline to 6-month follow up (post-intervention).

2. Instrumental Activities of Daily Living Score

   The Brief Instrumental Functioning Scale will be used to assess ability to perform in six functions: bathing, dressing, going to toilet, transferring, continence, and feeding. Each area is assessed on a five point scale; participants rated their ability to perform daily tasks on a 5-point scale (1 = no difficulty, 2 = a little difficulty, 3 = moderate difficulty, 4 = a lot of difficulty, 5 = unable to do). Items are summed to obtain a score with minimum and maximum values of 8 to 40, respectively, whereby higher scores represent greater difficulty performing ADLs.

   Measured: Change of ability to perform IADLs from baseline to 6-month follow up (post-intervention).

3. Depression

   Eight of the nine items in the Patient Health Questionnaire-9 were used to measure depression, rated on a 4-point scale of how frequently participants were bothered by the eight problems during a 2-week period (0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day). Items are summed to obtain a score with minimum and maximum values of 0 to 24, respectively, whereby higher scores represent greater depressive symptoms.

   Measured: Change in depression symptoms from baseline to 6-month follow up (post-intervention).

4. Falls Efficacy

   Participants rated their confidence they could do each of 10 activities without falling on a 10-point scale, with total scores ranging from 10 (not very confident) to 100 (very confident) using the Tinetti Falls Efficacy Scale. Thus, higher scores indicate greater efficacy related to falls.

   Measured: Change of falls efficacy from baseline to 6-month follow up (post-intervention).

5. Pain Interference With Usual Activities

   Pain interference with usual activities was assessed using an item from the 3-item PEG to assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G) on a 10-point Likert scale from 0 (does not interfere) to 10 (completely interferes).

   Measured: Change in the degree that pain interferes with usual activities from baseline to 6-month follow up (post-intervention).

6. Number of Falls in the Past Year or 6 Months

   Mean number of falls to the ground during the past year.

   Measured: Number of falls in the past year reported at 6-month follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Sep 2019
2. Study start17 Dec 2020
3. Primary completion25 Jul 2022
4. Study completion30 Jul 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Accidental FallStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.